Surgical robotic access system

ABSTRACT

The surgical robotic access system provides access for robotic instruments and/or actuators including the introduction, operation and withdrawal of such robotic manipulators into a body cavity without permitting the escape of pressurized fluid or gas. The surgical robotic access system also provides a multi-faceted range of movement without touching or effecting pressure on the opening in the patient&#39;s body cavity.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 15/253,455,filed Aug. 31, 2016, which claims priority to and benefit of U.S.Provisional Application No. 62/219,042, filed Sep. 15, 2015, the entiredisclosures of which are hereby incorporated by reference as if setforth in full herein.

BACKGROUND

This application relates generally to surgical access devices and moreparticularly to surgical access systems for surgical robotics.

Surgical robotics has been gaining acceptance and seeks to replace orassist in particular surgical procedures. In particular, some assistanceprovided by surgical robotics seeks to assist in complicated orrepetitive tasks. However, surgical robotics provides challenges whereprocedures performed by a surgeon without robotic assistance would notencounter. One such area is with surgical access devices used in surgeryto facilitate the introduction of various surgical instruments intonatural biological vessels, conduits, orifices, cavities, and otherinterior regions of the body. Surgical robotic instruments or actuatorsimpose other restrictions that are not encountered or not a limitationwith other surgical instruments or actuators, e.g., a surgeon's hand.Such challenges are further exasperated by the limited or restrictedsurgical area or environment. For example, the surgical environment mayrequire an introduction of laparoscopic or particular sized instrumentsor actuators into the abdomen of the body and/or introduced into regionsthat include fluid or gas under pressure.

SUMMARY

In accordance with various embodiments, a surgical robotic access systemis provided. The surgical robotic access system provides surgicalrobotic instruments and/or actuators access into a patient's body. Invarious embodiments, the surgical robotic access system comprises asurgical robotic access platform having a proximal portion disposedexternally to a patient's body and a distal portion positioned within apatient's body. The proximal portion of the surgical robotic accessplatform includes a flexible seal. A robotic insertion tube has aproximal end disposed away from the proximal portion of the surgicalrobotic access platform and has a distal end embedded in the flexibleseal of the surgical robotic access platform. The robotic insertion tubealso has a lumen extending between the proximal end of the roboticinsertion tube to the distal end of the robotic insertion tube throughwhich a surgical robotic manipulator is insertable therethrough andthrough the flexible material.

In various embodiments, the surgical robotic access system comprises asealing cap disposed externally to a patient's body in which the sealingcap includes a flexible seal. The surgical robotic access system alsocomprises a retractor with an outer ring removably connected to thesealing cap and an inner ring arranged to be positioned within thepatient's body and a robotic insertion tube comprising an upper or outeraccess connector and a lower or inner access connector. The outer accessconnector is arranged to be removably coupled to a robotic sleeve andthe inner access connector is embedded in the flexible seal of thesealing cap. The robotic insertion tube has a lumen extending throughthe outer access connector and the inner access connector and theflexible seal covering a portion of the lumen extending through theinner access connector and through which a surgical robotic manipulatorinsertable through the lumen is insertable through the flexible sealcovering the portion of the lumen.

In various embodiments, the surgical robotic access system comprises asealing cap disposed externally to a patient's body in which the sealingcap includes a flexible seal. The surgical robotic access system alsocomprises a robotic insertion tube comprising an outer access connectorand an inner access connector. The outer access connector is arranged tobe removably coupled to a robotic sleeve through which a roboticinstrument is insertable therethrough and the inner access connector isembedded in the flexible seal of the sealing cap to permanently affixthe inner access connector of the robotic insertion tube to the flexibleseal. The flexible seal has a first region with a first thicknesssurrounding the robotic insertion tube and a second region having asecond thickness disposed below the inner access connector of therobotic insertion tube. The first thickness of the flexible seal isgreater than the second thickness of the flexible seal to provide apredetermined insertion force.

In various embodiments, the surgical robotic access system comprises asealing cap disposed externally to a patient's body in which the sealingcap includes a flexible seal. The surgical robotic access system alsocomprises a robotic insertion tube comprising a first outer accessconnector and an inner access connector. The first outer accessconnector is removably coupled to a first robotic sleeve through which afirst robotic manipulator is insertable therethrough and the inneraccess connector is embedded in the flexible seal of the sealing cap topermanently affix the robotic insertion tube to the flexible seal. Asecond outer access connector is removably coupled to a second roboticsleeve through which a first robotic manipulator is insertabletherethrough. The first and second outer access connectors are arrangedto be removably coupled to the inner access connector of the roboticinsertion tube in that the first and second outer access connectors areinterchangeable with the inner access connector.

Many of the attendant features of the present invention will be morereadily appreciated as the same becomes better understood by referenceto the foregoing and following description and considered in connectionwith the accompanying drawings in which like reference symbols designatelike parts throughout.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a disassembled view of a surgical robotic access system inaccordance with various embodiments.

FIG. 2 is a perspective view of a surgical robotic access system inaccordance with various embodiments with portions of the system showntransparent.

FIG. 3 is a side view of a surgical robotic access system in accordancewith various embodiments with portions of the system shown transparent.

FIG. 4 is a perspective view of a surgical robotic access system inaccordance with various embodiments with portions of the system showntransparent.

FIG. 5 is a top view of a surgical robotic access system in accordancewith various embodiments.

FIG. 6 is a top view of a surgical robotic access system in accordancewith various embodiments with portions of the system shown transparent.

FIG. 7 is a top view of a surgical robotic access system in accordancewith various embodiments with portions of the system shown transparentor removed.

FIG. 8 is a side view of a sealing cap of a surgical robotic accesssystem in accordance with various embodiments.

FIG. 9 is a side view of a sealing cap of a surgical robotic accesssystem in accordance with various embodiments with portions of thesystem shown transparent.

FIG. 10 is a perspective view of a sealing cap of a surgical roboticaccess system in accordance with various embodiments.

FIG. 11 is a perspective view of a sealing cap of a surgical roboticaccess system in accordance with various embodiments.

FIG. 12 is a bottom view of a sealing cap of a surgical robotic accesssystem in accordance with various embodiments.

FIG. 13 is a perspective view of a robotic insertion tube of a surgicalrobotic access system in accordance with various embodiments.

FIG. 14 is a side view of a robotic insertion tube of a surgical roboticaccess system in accordance with various embodiments.

FIG. 15 is a perspective view of a robotic insertion tube of a surgicalrobotic access system in accordance with various embodiments.

FIG. 16 is a perspective view of a robotic insertion tube of a surgicalrobotic access system in accordance with various embodiments.

FIG. 17 is a perspective view of a sealing cap of a surgical roboticaccess system in accordance with various embodiments with portions ofthe sealing cap shown transparent or removed.

FIG. 18 is a perspective view of a sealing cap of a surgical roboticaccess system in accordance with various embodiments with portions ofthe sealing cap removed.

FIG. 19 is a cross-sectional view of a sealing cap of a surgical roboticaccess system in accordance with various embodiments with portions ofthe sealing cap removed.

FIG. 20 is a cross-sectional view of a sealing cap of a surgical roboticaccess system in accordance with various embodiments.

FIG. 21 is a perspective view of a surgical robotic access system inaccordance with various embodiments with a robotic sleeve connectedthereto and with portions of the sealing cap shown transparent.

FIG. 22 is a perspective view of a surgical robotic access system inaccordance with various embodiments with a robotic sleeve connectedthereto and with portions of the sealing cap shown transparent.

FIG. 23 is a perspective view of a surgical robotic access system inaccordance with various embodiments with a robotic sleeve and withportions of the sealing cap shown transparent.

FIG. 24 is a cross-sectional view of a surgical robotic access system inaccordance with various embodiments.

FIG. 25 is a top view of a surgical robotic access system in accordancewith various embodiments.

FIG. 26 is a cross-sectional view of a surgical robotic access system inaccordance with various embodiments.

FIG. 27 is a top view of a surgical robotic access system in accordancewith various embodiments.

FIG. 28 is a cross-sectional view of a surgical robotic access system inaccordance with various embodiments.

FIG. 29 is a top view of a surgical robotic access system in accordancewith various embodiments.

DETAILED DESCRIPTION

In accordance with various embodiments, a surgical robotic access systemprovides access for surgical robotic manipulators that includes but isnot limited to instruments, actuators and/or operative portions of asurgical robotic system. The robotic manipulators are roboticallycontrolled by the surgical robotic system autonomously or throughassistance of a surgeon without a surgeon in direct contact orphysically grasping the surgical robotic manipulator. The surgicalrobotic access system provides for the introduction, operation andwithdrawal of the surgical robotic manipulators into a body cavitywithout permitting the escape of pressurized fluid or gas. The surgicalrobotic access system also provides a multi-faceted range of movementwithout touching or effecting pressure on the opening in the patient.The surgical robotic access system in various embodiments provideslaparoscopic or single site access, insufflation and/or smokeevacuation.

In accordance with various embodiments, as shown for example in FIGS.1-29, the surgical robotic access system includes a surgical roboticaccess platform having a sealing cap 5 removably coupled to a retractoror protector 20. The sealing cap in various embodiments includes arobotic insertion tube 50. The robotic insertion tube provides accessfor surgical robotic manipulators, e.g., surgical robotic instruments oractuators. The sealing cap 5 comprises a flexible seal 15 that invarious embodiments is made of a flexible material such as a gelmaterial. The robotic insertion tube is embedded in flexible seal. Byembedding the robotic insertion tube in the flexible seal, any forcesthat may dislodge the tube is eliminated or greatly reduced.

As shown, for example, in FIGS. 14-16, the robotic insertion tube 50includes an inner access connector 55 and an outer access connector 58.In various embodiments, the inner access connector is embedded in theflexible seal 15. In various embodiments, the inner access connector istubular or cylindrical extending from a proximal end 52 a to a distalend 52 b and connects to or extends into a distal flange or base 53.Within the distal base or at the distal end of the inner accessconnector are a plurality of apertures 54 that provide access points oranchors to allow the flexible seal 15 to attach and hold the distal baseand the distal end of the inner access connector in place and embeddedin the flexible seal. The flexibility or resiliency of the flexible sealhowever allows the inner access connector 55 to float, pivot or move invarious directions unhindered but limited within the inner diameter orarea delimited by the sealing cap 5. However, the inner access connectoris embedded or otherwise fixed within or irremovable from the flexibleseal and thus cannot be removed or dislodged from the flexible seal.

The inner access connector 55 in various embodiments extends onlypartially through the flexible seal. As such, the flexible seal 15 ofthe sealing cap is disposed below or under portions of the inner accessconnector. The inner access connector defines or delimits an accesspassageway or lumen with an inner diameter 35 through which a roboticsmanipulator can extend there through and through the flexible seal. Theflexible seal provides an instrument seal around or sealingly engagesthe outer surface of the inserted robotic manipulator as the manipulatoris inserted, utilized or withdrawn from the inner access connector. Theflexible seal also provides a zero seal in various embodiments in theabsence of a robotic manipulator inserted in or through the inner accessconnector. Such seals prevent an escape of gas or fluids. In variousembodiments, as shown for example in FIG. 14, the inner access connectordefines an outer diameter 36 that is greater than the defined innerdiameter 35. The outer diameter 36 is similar to or equal to the outerdiameter of the outer access connector 58. Similarly, the inner diameter35 of the inner access connector is similar to or equal to the innerdiameter of the outer access connector. The distal base 53 of the inneraccess connector also defines a secondary or maximum outer diameter 37that is greater than the outer diameter 36 to further assist in thesecurement of the inner access connector to the flexible seal.

In various embodiments, as shown for example in FIGS. 17-19, theflexible seal has a cavity 151 disposed between the inner periphery ofthe inner access connector of the robotic insertion tube. As such, invarious embodiments, the flexible seal has a predetermined or predefinedmaximum height 46 and where the inner access connector is embedded inthe flexible seal, the flexible seal has a reduced height 47 relative tothe surrounding flexible seal. This cavity or reduced portion of theflexible seal (e.g., reduced height, area or volume of flexible seal) iswithin and where the inner access connector is attached thereto. Assuch, the diameter or width of the cavity 151 is equal to the outerdiameter 36 of the inner access connector. Also, the maximum diameter orwidth of the entire flexible seal is significantly greater than thediameter or width of the cavity 151. The cavity provides an area or freeregion or space for the flexible seal to displace as a surgical roboticmanipulator is inserted there through and thereby easing or reducinginsertion force. The displacement area however is also limited orconfined by the inner periphery of the inner access connector and thusbiases or causes the flexible seal to tend to seal against the insertedsurgical robotic manipulator. The cavity also provides limiteddisplacement of the flexible seal when pressurized from gases within thebody cavity to further enhance the seal with or without a manipulatorinserted there through.

The flexible seal disposed below the robotic insertion tube, e.g., thereduced portion of flexible includes a slit 152 to assist in insertionof a manipulator and sealing against the manipulator or in the absenceof the manipulator. In various embodiments, the slit 152 is a singleslit or a plurality of slits with one slit 153 orthogonal or angled fromanother slit 152 and positioned deeper or lower within the flexible sealthan the other slit 152. The reduced portion of flexible seal alsolimits and thus predefines the amount of material the surgical roboticmanipulator will encounter upon contact and insertion. With thispredefined and constant amount, the forces needed by a surgical roboticmanipulator to be inserted into and through the flexible seal can bepredefined or determined to provide haptic or tactile feedback to thesurgical robotic system to consistently identify when a surgical roboticmanipulator has been inserted initially, partially and completely intothe flexible seal, through the flexible seal or withdrawn from theflexible seal despite the geometry of the tips or distal end of themanipulator. In various embodiments, the distance or height 45 from thetop or proximal end of the robotic insertion tube 50 to the innersurface 160 of the flexible seal 15 is greater than the maximum height46 of the flexible seal 15. In various embodiments, the surgical roboticsystem includes a robotic sleeve surrounding and/or sealing orprotecting the robotic manipulator. As such, this distance or height ordifference in distance or height increases access for the robotic sleeveand enhances coupling of the robotic sleeve and freedom of movement ofthe robotic sleeve and the robotic insertion tube embedded in theflexible seal 15.

In various embodiments, the inner access connector has a distal or innerend 53 embedded in the flexible seal 15 and a proximal or outer end 52that is not embedded in the flexible seal and thus is disposed outside,proximate or above the outer surface 159 of the flexible seal. Thedistal end of the inner access connector does not extend through theflexible seal and thus is disposed above or doesn't extend pass orthrough the inner surface 160 of the flexible seal. The flexible sealseals the opening through the inner access connector and the pluralityof apertures around the inner access connector.

The flexible seal in various embodiments, as shown for example in FIGS.1-12, is contained or attached to a ring 11 and in various embodimentsan insufflation port 14, an evacuation port 12 or both are disposedthere through and through the flexible seal to access the body cavity.As such, gas or fluid such as insufflation gas can be externallysupplied via an inlet 141 of the insufflation port 14 from a gas sourceoutside or external to the patient and the surgical robotic accesssystem into the patient through an outlet 142 of the insufflation portwhile the flexible seal prevents any gas or fluid from escaping.Similarly, gas or fluid such as smoke may be extracted from within thepatient through the inlet 122 of the evacuation port 12 and pulled outexternally through an outlet 121 of the evacuation port 12 into anappropriate canister, suction or evacuation system to properly disposeof the potentially harmful or disruptive gas or fluid. In variousembodiments, an outer portion or periphery of the flexible seal iscoupled to the ring 11 and in one embodiment is molded to a plurality ofapertures disposed along the periphery of the ring. In variousembodiments, the ring 11 of the sealing cap includes a pivotably coupledlatch 157 along with a stationary ledge or flange 156 to assist inremovably coupling the sealing cap to the protector. In variousembodiments, the ring and flexible seal are made of the same materialand thus together form a monolithic structure.

In the illustrated embodiment, a raised portion 158 of the flexible sealsurrounds the cavity 151 to further secure or reinforce the attachmentof the robotic insertion tube to the flexible seal. In variousembodiments, the raised portion is removed to provide the flexible seala uniform height or thickness throughout the seal. In variousembodiments, a center cavity 154 is disposed within the cavity 151 tofurther assist in the insertion of a manipulator and sealing against themanipulator or in the absence of the manipulator. As such, the centercavity provides another reduced layer of thickness or increasedflexibility relative to the surrounding cavity 151 and the surroundingflexible seal, e.g., the raised portion of flexible seal or the materialwithin the cavity or between the cavity and the edge or outer peripheryof the sealing cap.

In various embodiments, the inner and outer access connectors 55, 58 ofthe robotic insertion tube 50 are separate components. In variousembodiments the inner access connector remains fixed and unchanged whilethe outer access connector may be disconnected and replaced orinterchanged with another outer access connector with a differentrobotic coupling interface. As such, in various embodiments, the inneraccess connector and the outer access connector include matingconnections 51, 56 such as threading, snaps or the like to removablycouple the outer and inner access connectors together. Accordingly, theouter access connector can be interchanged with other outer accessconnectors that provide the associated connection particular for aspecific robotic manipulator and/or sleeve. For example, FIG. 16illustrates an outer access connector 58′ similar to the outer accessconnector 58 but having apertures 60 to releasably connect to tabs ordetents of a different robotic coupling interface of a different roboticsleeve. The apertures 60 do not extend into the lumen of the outeraccess connector thereby maintaining the seal integrity within therobotic insertion tube. Other portions of the outer access connector mayalso vary such as the seal on it outer surface along with differentsizes and shapes to accommodate the varied coupling interface for otherrobotic sleeves. The different or varied robotic sleeves may be used foror to identify different robotic manipulators or other identifyingindicia of the robotic manipulator operation, surgical robotic system orsurgical procedure.

In cases where the outer access connector is permanently affixed to ornot otherwise removable from the inner access connector to enhancestability of the robotic insertion tube, to interchange different outeraccess connectors or in particular different robotic coupling interfacesof the outer access connectors to accommodate different robotic sleeves,the entire sealing cap is replaceable with a different sealing cap. Assuch, a first sealing cap can include an inner access connector embeddedin the flexible seal of the sealing cap with an outer access connectoraffixed to the inner access connector and a separate second sealing capcan include an inner access connector embedded in the flexible seal ofthe sealing cap with an outer access connector affixed to the inneraccess connector with this outer access connector having a different orspecialized robotic coupling interface relative to the other roboticcoupling interface of the outer access connector of the first sealingcap. As such, the first sealing cap can be interchanged with the secondsealing cap as required for the corresponding needed robotic couplinginterface. This can also be the case for access connectors that can beseparated to provide alternative connections or quick changes if desiredor required by the particular surgical or robotic system or procedure.

The outer access connector 58 in various embodiments provides a targetarea that is identifiable by the surgical robotic system to sense and/orlocate for the insertion of a surgical robotic manipulator therethrough. In various embodiments, the outer access connector includes arobotic coupling interface configured to, engage, mate or sealingly matewith a corresponding robotic coupling interface of a robotic sleeve 500.In FIGS. 21-23, for example, the robotic coupling interface of the outeraccess connector includes a plurality of pins 59 and the roboticcoupling interface of the robotic sleeve includes one or more slots 503within a rotatable collar 502 to engage with the plurality of pins toform a bayonet like connection between the outer access connector andthe robotic sleeve. In various embodiments, the robotic sleeve, theouter access connector or both includes a seal to seal the connectionbetween the robotic sleeve and the robotic insertion tube. In oneembodiment, the seal includes one or more compressible seals such asO-ring 57 disposed partially within one or more grooves in the outersurface of the outer access connector 58. In various embodiments, therobotic sleeve 500 is attached by a user to the outer access connector58. The robotic manipulator, e.g., exemplary robotic instrument 504, isrobotically controlled by a surgical robotic system autonomously orthrough assistance of a surgeon without a surgeon in direct contact orphysically grasping the surgical robotic manipulator. In variousembodiments, both the robotic sleeve and the robotic manipulators arerobotically controlled. With the robotic sleeve 500 attached to theouter access connector 58, the surgical robotic system can identify orhas a fixed or well-defined location of the surgical robotic accesssystem and thus the opening in the patient. Additionally, the locationis simplified by limiting the frame of reference relative to thepatient. The surgical robotic manipulator can be maneuvered through theflexible robotic housing or tube 501 and collar 502 of the roboticsleeve 500 and into and through the surgical robotic access systemwithout potential missteps as to the location of the opening of thepatient.

In various embodiments, the outer access connector and inner accessconnector are integrated or locked together to form a single monolithicstructure and/or made from the same material. In various embodiments,the outer access connector is adhered to the inner access connector. Invarious embodiments the outer access connector is removably coupled tothe inner access connector, e.g., via snaps, tabs, pins, slots or othersimilar connections and as such the outer access connector can beremoved if not needed or interchanged with another outer accessconnector with a different coupling interface as may be needed with adifferent robotic sleeve, manipulator or system. The robotic sleeveprovides flexibility and/or protection to the surgical roboticmanipulator extendable through and out the distal end of the sleeve. Theouter access connector to the robotic sleeve connection ensures that thesurgical robotic system remains connected to the surgical robotic accesssystem and thus reduces or eliminates the need for the surgical roboticsystem to locate the opening in the patient or the surgical roboticaccess system.

The distal ends of the surgical robotic manipulator in variousembodiments are removable and hot swappable with other distal ends ofthe surgical robotic manipulator that are arranged to preform specificsurgical functions, such as stapling, electro-cautery, grasping,viewing, cutting and the like. In various embodiments, the outer accessconnector provides a fixed platform and seal for the robotic sleeve. Therobotic sleeve remains static and in various embodiments the roboticcoupling interface with the robotic sleeve and outer access connectoralso remains static. The surgical robotic manipulators can vary in shapeand sizes and thus the inner access connector including the reduced orisolated flexible seal provides an adaptable yet static sealingarrangement to seal against the varied shapes and sizes of the surgicalrobotic manipulators or in the absence of a surgical roboticmanipulator. The flexible seal also does not damage or disrupt thesurgical robotic manipulator. The flexible seal surrounding the inneraccess connector also facilitates the seal with the opening in the bodyand allows freedom of movement of the outer access connector whichfacilitates the seal with or to robotic sleeve and manipulator andreduces potential damage to the robotic sleeve and/or manipulator due tooff axis movements.

In various embodiments, a surgical robotic access system provides adouble seal arrangement for a surgical robotic manipulator to beinserted there through or in the absence of a manipulator. The surgicalrobotic access system in various embodiments includes an outer accessconnector to removably attach to and seal with a robotic sleeve and aninner access connector to fixedly attach the outer and inner accessconnectors to a sealing cap attached to the patient and disposed overand sealing the opening in the patient. The flexible seal of the sealingcap in which the inner access connector is embedded or fixed allowsfreedom of movement of the outer and inner access connectors withoutadding stress or tension on the surgical robotic manipulator, roboticsleeve or the patient. The flexible seal within and/or below the inneraccess connector provides a seal for a surgical robotic manipulator tobe inserted there through or in the absence of a manipulator insertedthrough the flexible seal. The reduced portion of the flexible sealdefined and/or confined by the inner access connector provides aconsistent density or consistency to provide a predefined or pre-knownor predictable insertion force that may be used to generate hapticfeedback or other similar sensor information to be recognized by thesurgical robotics system to identify and/or simulate the insertion andwithdrawal of the surgical robotic manipulator.

The sealing cap 5 of a surgical robotic access platform in variousembodiments is incorporated with or removably attached to a retractor orprotector 20 that provides retraction and/or protection of the incisionor opening in the patient. In various embodiments, the retractorincludes a sleeve, sheath or tube 22 extending between an inner ring 23placed inside the patient and an outer ring 21 placed outside thepatient. Both rings can be rigid, flexible or any combination thereof.The sheath is flexible and cylindrical. In various embodiments, thesheath has another shape, such as an oval or a more complex shape, isadjustable, is transparent or any combinations thereof. In variousembodiments, the length of the sheath is adjustable by varying thelocation of the outer and inner rings or by gathering or windingportions of the sheath around the outer ring, the inner ring, anadaptor, other ring or the like and any combination thereof. In variousembodiments, the sheath is non-adjustable defining a fixed length anddiameter access channel. In various embodiments, the sheath includes oneor more coatings such as a lubricious coating, anti-microbial coating orboth. Examples of sealing caps, retractors and/or protectors aredescribed in U.S. Patent Publication No. 2007/0088204 A1, the disclosureof which of incorporated by reference as if set forth in full herein.Examples of a flexible seal or material including gel material aredescribed in U.S. patent application Ser. No. 10/381,220, filed Mar. 20,2003, the disclosure of which is hereby incorporated by reference as ifset forth in full herein.

In various embodiments, the sealing cap covers the proximal or outerportion of the retractor/protector. In various embodiments, the sealingcap provides additional access areas or portions. In the illustratedembodiment, the sealing cap includes a flexible seal or cover made of aflexible material, e.g., gel material, surrounding the robotic orcentral insertion tube and through which instruments may be inserteddirectly there through for additional access into the patient. Invarious embodiments, 12 mm and 5 mm removable access ports 38, 39 areprovided for auxiliary surgical instruments or surgical roboticmanipulators and are inserted around the robotic insertion tube. Invarious embodiments, the removable access ports comprise of a cannulawith an attached or integrated seal assembly with an instrument seal,zero seal or both. The cannula in various embodiments having one or moresupport structures on the outer surface of the cannula to removablysecure the removable access port to the flexible seal. In variousembodiments, auxiliary surgical instruments are insertable directlythrough the flexible seal in portions around or adjacent the roboticinsertion tube. The flexible seal provides a seal around or sealinglyengages an outer surface of the surgical instruments as the instrumentis inserted, utilized or withdrawn from the flexible seal around theinner access connector and a seal in various embodiments in the absenceof a surgical instrument inserted in the flexible seal around the inneraccess connector.

The retractor/protector of a surgical robotic access platform provides astable platform to connect the sealing cap to the patient. The stableplatform allows movement of the robotic insertion tube without orreducing any additional movement or forces caused by any movement of therobotic insertion tube in the flexible seal. As such, the flexible sealreduces or dissociates movement of the flexible seal caused by movementof the robotic insertion tube relative to the rest of the sealing capand the patient and the sealing cap attached to the retractor/protectorfurther dissociates movement of the sealing cap on the patient caused bymovement of the flexible seal of the sealing cap. Theretractor/protector also atraumatically retracts the opening in thepatient to increase range of access or mobility of the roboticmanipulators and positions the tissue, around and through the opening,away from potential contact or trauma from the surgical roboticmanipulators.

In various embodiments, an instrument shield or retractor shield 25 isprovided to prevent or reduce potential damage to the retractor orprotector and/or direct off-axis instruments towards the center oropening in the patient. In various embodiments, the sealing cap may beconnected directly to the patient via sutures or adhesive and may beprovided with or without the retractor, shield or both. In variousembodiments, the surgical robotic access system provides access into apatient's body cavity for a 22 mm diameter surgical robotic manipulator.The surgical robotic access system provides a seal (zero-seal) when therobotic manipulator is not inserted through the surgical robotic accesssystem. The surgical robotic access system also provides a seal(instrument seal) when the robotic manipulator is inserted through thesurgical robotic access system. The seal prevents the loss or escape offluids or gases. The surgical robotic access system in variousembodiments also provides access for introducing or removing of gas orfluids such as insufflation gas, smoke or the like. The surgical roboticaccess system provides protection from distal tips of the roboticmanipulator from damaging the surgical robotic access system. Thesurgical robotic access system in various embodiments provides auxiliaryports, e.g., a 5 mm, 12 mm or other dimensioned ports or access forsimilarly sized surgical instruments.

In various embodiments, as shown for example in FIGS. 24-25, a surgicalrobotic access system is provided in which a sealing cap includesprotectors or shield leaves 31 to protect the flexible seal 15 attachedto or integrated with a ring, cap or cover 11. In various embodiments,the protectors are embedded in the flexible seal below the roboticinsertion tube 50 and inside the inner periphery of the sealing cap 5.In various embodiments, the protectors are positioned between the distalend of the robotic insertion tube and the inner surface of the flexibleseal. The protectors are confined within the area or space adjacent tothe robotic insertion tube to allow additional access through thesurrounding flexible seal as well as to allow freedom of movement of theflexible seal unencumbered or obstructed by the protectors. The flexibleseal in one embodiment is a gel material and in various embodiments anupper surface of the protectors are exposed within the lumen of therobotic insertion tube and a lower and/or side surfaces of theprotectors are surrounded by or directly attached and embedded in theflexible seal.

The protectors in one embodiment are cast into the flexible seal toprotect or reinforce the flexible seal or material from being torn orpunctured by the tips of the surgical robotic manipulators in such a wayto effectively disrupt or make ineffective the zero sealing orinstrument sealing capabilities of the sealing cap In variousembodiments the protectors are made out of a soft and durable material,such as LDPE, to provide a lubricious surface for the tips of the robotmanipulators to ride against during insertion or withdrawal of the robotmanipulators. In various embodiments, the protectors are made from amaterial different, more durable and rigid or any combination thereofthan the material of the flexible seal. In various embodiments, theprotectors 31 are a plurality of planar curved or angled plastic orfabric sheets. In various embodiments, two protector sheets, eachidentical and mirror images of each other, meet together at an edge andin various embodiments over a midline of flexible seal or above theslit. The protectors having one edge elevated above the edge at themidline of the flexible seal provide a tapered entry to facilitatemovement of the protectors and to direct the inserted roboticmanipulator towards the slit in the flexible seal. In variousembodiments, the flexible seal or material directly under the protectorsare correspondingly shaped and sized to accommodate the shape and sizeof the protectors.

In various embodiments, the robotic insertion tube 50 comprises an outeraccess connector 58 that includes a robotic coupling interface such asbayonet pins and in various embodiments an inner access connector 55connected to the outer access connector with the inner access connectorcast or molded into the flexible material and in various embodimentsabove the protectors. The outer access connector in various embodimentshas an O-ring fitted around the outer periphery of the outer accessconnector to provide a seal with a mating end or robotic couplinginterface of a surgical robotic sleeve. The outer access connector assuch maintains a seal with the robotic sleeve even when the seal in theflexible seal is disrupted by the insertion of a robot manipulator.

In various embodiments, as shown for example in FIGS. 26-27, a doubleduckbill seal 41 is cast into the flexible seal 15 to provide anadditional or separate zero seal or seal in absence of a surgicalrobotic manipulator. The duckbill seal in various embodiments is made ofa material different from the material of the flexible seal 15. Theduckbill seal is compressible by the surrounding flexible seal tofurther enhance the seal of the duckbill seal. In various embodiments,the duckbill seal does not extend through the flexible seal and insteadis completely embedded in the flexible seal to further enhance the sealof the sealing cap and the duckbill seal. The protectors, illustrated inFIGS. 24-25, may be included and may proceed the duckbill seal.

In various embodiments, as shown for example in FIGS. 28-29, a surgicalrobotic access system is provided including robotic insertion tube 50embedded in a flexible seal 15 of a sealing cap 5, 12 mm trocar oraccess port 71 with an additional stopcock 14 and asimplified/exemplified 5 mm auxiliary port 38. In various embodiments,the robotic insertion tube includes a duckbill seal 61 that provides aseparate or additional zero seal for the robotic insertion tube. In theillustrated embodiment, the robotic insertion tube includes anevacuation and/or insufflation port 12 to remove or introduce gas, e.g.,insufflation gas, to or from an external source through the roboticinsertion tube and from or into the patient's body cavity. As such, theduckbill seal also provides a zero seal as gas or fluids are removedand/or introduced. In various embodiments the robotic insertion tube andthe access ports are utilized together to increase triangulationmanipulation or viewing for the surgical procedure.

In accordance with various embodiments, the dashed line 18 represents anexemplary incision size of the patient and in which the roboticinsertion tube and the other ports are delimited or confined within. Thedashed lines 24 represents or exemplifies the protector and its film orsheath that may be twisted prior to its insertion into the opening inthe patient. The film twisted can further assist in sealing the openingof the patient. In various embodiments, the dashed lines 28 represent orexemplify the body wall and the sheath of the retractor retracting theopening in the patient to ease access into the patient. In theillustrated embodiments, one or more of the components are showntransparent or translucent to better show some of the underlyingcomponents or features otherwise hidden by the flexible seal or sealingcap or other portions thereof. In various embodiments, the dashed line18 outlines or exemplifies a different consistency or flexibility of theflexible seal relative to the surrounding material and in variousembodiments the flexible seal within the dashed line 18 is firm or morerigid relative to the surrounding material and thus moves or translatesfreely relative to the ring while the robotic insertion tube remainsstatic relative to the flexible seal immediately surrounding the tube.The dashed lines 3, 5 generally represent or exemplify the upper andlower surfaces of the body wall of a patient. The dashed line 7represents or exemplifies the mid-line or longitudinal axis of thesurgical robotic access system and in various embodiments represents aninitial incision or opening in the patient.

In the illustrated embodiments, it is exemplified that the sealing capmay have different sizes and dimensions along with the robotic insertiontube. The dimensions and sizes may be dictated or determined based onthe surgical procedures or the surgical robotic system. Similarly, theshape and materials of the access system may vary to optimize thesurgical site space or connectivity to the surgical robotic system. Therobotic or central insertion tube although provided as a tube orcylindrical may be of varied shapes and dimensions such as hour-glass,frustoconical or the like to optimize the surgical site space or sealingengagement with surgical robotic instruments or the sealing cap.

In various embodiments, the surgical robotic access system provides aconsistent outer access connector and seal for a robotic sleeve and aconsistent inner access connector and seal for a surgical roboticmanipulator. Throughout a surgical procedure, the surgical roboticmanipulator may be interchanged with other surgical robotic manipulatoreach having differing or varying geometry and/or dimensions.

The above description is provided to enable any person skilled in theart to make and use the surgical robotic access system described hereinand sets forth the best modes contemplated by the inventors of carryingout their inventions. Various modifications, however, will remainapparent to those skilled in the art. It is contemplated that thesemodifications are within the scope of the present disclosure. Differentembodiments or aspects of such embodiments may be shown in variousfigures and described throughout the specification. However, it shouldbe noted that although shown or described separately each embodiment andaspects thereof may be combined with one or more of the otherembodiments and aspects thereof unless expressly stated otherwise. It ismerely for easing readability of the specification that each combinationis not expressly set forth. It is therefore also to be understood thatthe system or devices may be practiced otherwise than specificallydescribed, including various changes in the size, shape and materials.Thus, embodiments described should be considered in all respects asillustrative and not restrictive.

The invention claimed is:
 1. A surgical robotic access system providingrobotic manipulator access into a patient's body, the surgical roboticaccess system comprising: a sealing cap disposed externally to apatient's body, the sealing cap including a ring, a flexible seal and atleast one shield leaf, the flexible seal attached to the ring and the atleast one shield leaf embedded in the flexible seal, the flexible sealand the at least one shield leaf disposed within an inner periphery ofthe ring; a retractor comprising an outer ring removably connected tothe ring of the sealing cap and an inner ring arranged to be positionedwithin a patient's body; a robotic sleeve; and a robotic insertion tubecomprising a proximal end and a distal end, the proximal end removablyconnected to the robotic sleeve and the distal end embedded andpermanently affixed in the flexible seal of the sealing cap, the roboticinsertion tube having a lumen extending from a proximal opening at theproximal end of the robotic insertion tube to a distal opening at thedistal end of the robotic insertion tube, the flexible seal disposedaround and under the distal end of the robotic insertion tubeencompassing the distal end of the robotic insertion tube and coveringthe distal opening at the distal end of the robotic insertion tube,through which a surgical robotic manipulator insertable through thelumen is insertable through the at least one shield leaf and theflexible seal covering the distal opening at the distal end of therobotic insertion tube.
 2. The system of claim 1 wherein the at leastone shield leaf comprises an upper surface exposed within the lumen ofthe robotic insertion tube and a lower surface surrounded by andembedded in the flexible seal.
 3. The system of claim 1 wherein the atleast one shield leaf is disposed directly under the distal opening atthe distal end of the robotic insertion tube.
 4. The system of claim 3wherein the flexible seal is made of gel material.
 5. The system ofclaim 4 wherein the at least one shield leaf has a lubricious surface.6. The system of claim 4 wherein the at least one shield leaf is morerigid than the flexible seal.
 7. The system of claim 4 wherein the atleast one shield leaf is made of a material different from the flexibleseal.
 8. The system of claim 7 wherein the at least one shield leaf is aplanar angled fabric sheet.
 9. The system of claim 7 wherein the atleast one shield leaf is a planar angled plastic sheet.
 10. The systemof claim 9 wherein the at least one shield leaf comprises a first shieldleaf and a second shield leaf, both the first and second shield leavesbeing identical and mirror images of each other.
 11. The system of claim10 wherein the first and second shield leaves meet together at an edgeand over a midline of the flexible seal.
 12. The system of claim 10wherein the first and second shield leaves meet together at an edge andover a slit in the flexible seal.
 13. The system of claim 12 wherein theproximal end of the robotic insertion tube includes a plurality of pinsextending form an outer surface and periphery of the proximal end of therobotic insertion tube.
 14. The system of claim 13 wherein the roboticsleeve has at least one slot to engage at least one pin of the pluralityof pins of the robotic insertion tube and removably couple and sealinglyengage the proximal end of the robotic insertion tube to the roboticsleeve.
 15. The system of claim 14 wherein the proximal end of therobotic insertion tube includes an o-ring disposed around the outersurface and periphery of the proximal end of the robotic insertion tube.16. The system of claim 12 further comprising a plurality of removableaccess ports insertable through the flexible seal and disposed aroundthe robotic insertion tube, the plurality of removable access portsincluding a first removable access port and a second removable accessport, the first removable access port being larger than the secondremovable access port.
 17. The system of claim 16 wherein the firstremovable access port comprises a cannula, an instrument seal and a zeroseal.
 18. The system of claim 17 further comprising an insufflation portdisposed through the ring and the flexible seal.
 19. The system of claim18 wherein portions of the flexible seal near and directly surroundingthe robotic insertion tube is raised relative to portions of theflexible seal near the ring of the sealing cap, the portions of theflexible seal near and directly surrounding the robotic insertion tubehaving a thickness greater than a thickness of the portions of theflexible seal near the ring of the sealing cap.
 20. The system of claim19 wherein a distal most end of the robotic insertion tube is disposedabove a lower surface of the flexible seal.